BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1791200 · Received August 2, 2010

    Report

    Report Number
    2017233-2010-00357
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 2, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: (B)(4) ¿ ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING FOUR GORE EXCLUDER AAA ENDOPROSTHESES. THE TRUNK-IPSILATERAL LEG COMPONENT WAS INTRODUCED VIA THE RIGHT ILIAC ARTERY AND WAS LANDED AS INTENDED. THE CONTRALATERAL LEG COMPONENT WAS ADVANCED THROUGH THE LEFT ILIAC. AFTER THE CONTRALATERAL GATE WAS CANNULATED, THE GUIDEWIRE CAME OUT OF THE CONTRALATERAL GATE. AFTER MULTIPLE ATTEMPTS, THE GATE WAS CANNULATED AGAIN WITH THE CONTRALATERAL LEG COMPONENT. AFTER THE CONTRALATERAL GATE WAS CANNULATED A SECOND TIME, THE SHEATH WAS PULLED BACK AND THE PROXIMAL END OF THE DEVICE WAS 4-5 MM ABOVE THE FLOW DIVIDER IN THE TRUNK-IPSILATERAL LEG COMPONENT. THE PHYSICIAN COULD NOT PULL THE DEVICE CATHETER DOWN ANY FURTHER. THE PROXIMAL OLIVE ON THE CONTRALATERAL LEG COMPONENT WAS MOVEABLE BUT THE DISTAL OLIVE WOULD NOT MOVE. THE DEVICE WAS DEPLOYED IN THIS LOCATION. WHEN THE DEVICE CATHETER FOR THE CONTRALATERAL LEG COMPONENT WAS WITHDRAWN FROM THE PATIENT, THE DISTAL OLIVE WAS MISSING. THE PHYSICIAN USED A SNARE TECHNIQUE AND WAS ABLE TO REMOVE THE AMPLATZ WIRE AND THE DISTAL TIP OF THE DEVICE CATHETER FROM THE PATIENT. THE MANIPULATION CAUSED THE TRUNK-IPSILATERAL LEG COMPONENT TO MIGRATE DISTALLY INTO THE ANEURYSM SAC. THE PHYSICIAN EXTENDED THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT WITH TWO AORTIC EXTENDER COMPONENTS. THE ANEURYSM WAS EXCLUDED. AT THE END OF THE PROCEDURE, IT WAS NOTED UNDER FLUOROSCOPY, THAT THE LEFT RENAL ARTERY WAS OCCLUDED. IT WAS NOT OCCLUDED PRIOR TO THE PROCEDURE. THE OCCLUSION WAS NOT CAUSED BY ANY OF THE GORE EXCLUDER AAA ENDOPROSTHESES COVERING THE ORIFICE TO THE LEFT RENAL ARTERY. IT APPEARED THAT A PIECE OF CALCIUM HAD DISLODGED DURING THE PROCEDURE AND CREATED THE OCCLUSION. A SMALL TYPE II ENDOLEAK FROM THE LUMBARS WAS NOTED AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 7881971

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other